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Health Advocate Support for Liver Transplant Complications (HEAL-Tx Pilot Trial)

N/A
Recruiting
Led By Sharad Wadhwani, MD, MPH
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 90 days, and 180 days
Awards & highlights
No Placebo-Only Group

Summary

This trial assesses an intervention to support pediatric liver transplant patients by facilitating medical care, finances and access to resources, with the goal to improve communication and self-management for better outcomes.

Who is the study for?
This trial is for children under 18 who have had a liver transplant. They and/or their guardians must understand English or Spanish, agree to the study's terms, and be chosen by the transplant team as suitable participants. It excludes adults, non-English/Spanish speakers, those unwilling to complete surveys, wards of the state, and non-US residents.
What is being tested?
The HEAL-Tx Pilot tests if adding a Health Advocate to the pediatric liver transplant team helps with care coordination, financial support like taxi vouchers, and linking families to community resources. The goal is to see if this improves self-care and communication between families and healthcare providers.
What are the potential side effects?
Since this trial involves a health advocate intervention rather than medication or medical procedures, traditional side effects are not expected. However, there may be indirect impacts on family dynamics or emotional responses that will be monitored.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 90 days, and 180 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 90 days, and 180 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in caregiver experience
Secondary study objectives
A qualitative assessment of caregiver and healthcare provider satisfaction with the Health Advocate intervention.
Change in medication adherence using MLVI
The quality of health advocate interactions with the participants, healthcare team, and community-based resources.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
This is a single arm pilot intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Health Advocate
2017
N/A
~40

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,593 Previous Clinical Trials
14,887,940 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,463 Previous Clinical Trials
4,337,393 Total Patients Enrolled
Sharad Wadhwani, MD, MPHPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
520 Total Patients Enrolled

Media Library

Health Advocate Clinical Trial Eligibility Overview. Trial Name: NCT05700799 — N/A
Acute Lymphoblastic Leukemia Research Study Groups: Intervention
Acute Lymphoblastic Leukemia Clinical Trial 2023: Health Advocate Highlights & Side Effects. Trial Name: NCT05700799 — N/A
Health Advocate 2023 Treatment Timeline for Medical Study. Trial Name: NCT05700799 — N/A
~2 spots leftby Jun 2025
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